Table 1

Studies evaluating commercially available assays detecting urinary lipoarabinomannan (LAM) for diagnosis of tuberculosis (TB) in patients with culture-confirmed disease
Study LAM assay Country Study population Total subjects (n) HIV+ subjects with culture+ TB (n) HIV- subjects with culture+ TB (n) Culture method Sensitivity of sputum microscopy % (95%CI) Sensitivity of LAM assays for culture+ TB % (95%CI) Overall specificity % (95%CI) LAM results and non-tuberculous mycobacteria
HIV+ subjects HIV- subjects % subjects with NTM who tested LAM+ % false- positive LAM with NTM cultured
Boehme et al. 2005 [30] MTB ELISA, first prototype (Chemogen Inc) Tanzania Out-patient TB suspects 334 85 34 LJ culture 62 (54-70) 81 (71-88) 74 (57-86) 99 (94-100) NS NS
Lawn et al. 2009 [31] MTB ELISA, second prototype (Chemogen Inc) South Africa Active screening of HIV+ out-patients pre-ART 235 58 0 Automated liquid culture 14 (7-25) All: 33 (22-46) N/A 100 (98-100) None None
CD4>100: 13 (4-33)
CD4 50-100: 41 (22-64)
CD4<50: 67 (44-84)
Mutetwa et al. 2009 [32] MTB ELISA, second prototype (Chemogen Inc) Zimbabwe Out-patient TB suspects 397 140 Not stated LJ culture 75 (67-81) 52 (43-62) 21 (9-37) 89 (81-94) NS NS
Reither et al. 2009 [23] MTB ELISA second prototype (Chemogen Inc) Tanzania Out-patient TB suspects 291 50 19 LJ and automated liquid culture 70 (58-79) 62 (48-74) 21 (8-44) 88 (79-94) 4/45 (8.9%) 4/14 (29%)
Daley et al. 2009 [33] MTB ELISA, second prototype (Chemogen Inc) India Out-patient TB suspects 200 5 40 LJ and liquid culture 79* (66-89) 20 (1-70) 18 (8-32) 88 (81-92) NS NS
Shah et al. 2009 [34] Clearview TB ELISA (Inverness Medical Innovations) South Africa In-patient HIV+ TB suspects 499 167 14 Automated liquid culture 42 (36-50) All: 67 (59-74) 14 (3-41) 96 (91-99) NS NS
CD4>200 55 (41-69)
CD4150-200: 14 (4-58)
CD4150-200: 56 (30-80)
CD450-100: 71 (51-87)
CD4<50: 85 (73-93)
Dheda et al. 2010 [24] Clearview TB ELISA (Inverness Medical Innovations) South Africa Out-patient TB suspects 500 44 80 Automated liquid culture 65 (57-72) All: 21 (11-35) 6 (3-14) 99 (97-100) NS NS
CD4<200: 37 (19-59)
Gounder et al 2011 [35] Clearview TB ELISA (Inverness Medical Innovations) South Africa Active screening of HIV+ out-patients pre-ART or on ART 422 30 0 Automated liquid culture 27 (12-48) All: 32 (16-52) N/A 98 (96-99) 4/7 (57%) 4/8 (50%)
CD4200-350: 10 (1-72)
CD4<200: 35 (16-57)
CD4<50: 56 (21-86)
Lawn et al. 2011 [12] Clearview TB ELISA (Alere Inc.) South Africa Active screening of HIV+ out-patients pre-ART 516 85 0 Automated liquid culture 28 (19-39) All: 27 (18-38) N/A 98 (96-99) 2/8 (25%) 2/8 (25%)
CD4>200: 8 (1-26
CD4<200: 36 (24-49)
CD4<150: 44 (29-59)
CD4<100: 48 (29-68)
CD4<50 61 (36-83)
Lawn et al 2012 [12] Determine TB-LAM Ag point-of-care test South Africa Active screening of HIV+ out-patients pre-ART 516 85 0 Automated liquid culture 28 (19-39) All: 28 (19-39) N/A 99 (97-100) 2/8 (25%) 2/6 (33%)
CD4>200: 4 (0-20)
CD4<200: 39 (27-53)
CD4<150: 46 (31-61)
CD4<100: 52(33-71)
CD4<50: 67 (41-87)
Peter et ak. 2012 [13] Determine TB-LAM Ag point-of-care test South Africa In-patient HIV+ TB suspects 281 TB suspects + 88 non-TB controls 116 0 Automated liquid culture 56 (45-66) Multiple different analyses using different gold standards and different assay cut-offs: see text for summary N/A See text NS NS

*of all TB diagnoses, not just culture-confirmed. 95%CI = 95% confidence intervals. Where 95%CI were not calculated in the original manuscripts, these have been calculated using the Wald method.

LJ = Lowenstein Jensen slopes. ELISA = enzyme-linked immunosorbent assay. ART = antiretroviral therapy. NS: not stated.

Lawn

Lawn BMC Infectious Diseases 2012 12:103   doi:10.1186/1471-2334-12-103

Open Data